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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, feeding
510(k) Number K180236
Device Name VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
Applicant
VR MEDICAL TECHNOLOGY CO., LTD
No. 90 Gaoxin Rd.
Zhouzhuang,  CN 215325
Applicant Contact Lee Pan
Correspondent
VR Medical c/o ProMedic, LLC
131 Bay Point Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number876.5980
Classification Product Code
FPD  
Subsequent Product Codes
KNT   PIF  
Date Received01/29/2018
Decision Date 01/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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